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Goodell v. Bayer Healthcare Pharmaceuticals Inc.

United States District Court, D. Massachusetts

September 30, 2019



          Indira Talwani United States District Judge.

         In 2010, Plaintiff Stephen Goodell was administered an injection of Magnevist in connection with an MRI. Magnevist is a gadolinium-based contrast agent (“GBCA”) manufactured, marketed, and sold by Defendants Bayer Healthcare Pharmaceuticals Inc., Bayer Corporation, and Bayer Healthcare LLC (collectively “Bayer”). Plaintiff alleges that the gadolinium from the 2010 injection remains in his body and has caused him injury. Before the court is Bayer’s Motion to Dismiss [#54]. Bayer contests the court’s personal jurisdiction over Bayer. Bayer also challenges Plaintiffs claims for relief, arguing that: 1) Plaintiffs claims are preempted by federal law regulating the labelling of Magnevist, 2) the complaint fails to identify a cognizable injury and causally connect that injury to Magnevist, 3) Plaintiff cannot obtain relief under Massachusetts’ Consumer Protection Law because of a statutory exemption for government-approved activity, 4) Plaintiff does not have standing to seek injunctive relief, and 5) that Plaintiffs claims are time-barred. The court ALLOWS Bayer’s motion to dismiss for failing to sufficiently allege personal jurisdiction over Bayer and because the claims, as pleaded, are federally preempted. However, Plaintiff is granted leave to amend the complaint.

         I. Factual Background as Set Forth in the Complaint

         In 2010, when Plaintiff was administered Magnevist, studies showed that the specific type of GBCA contained in Magnevist (linear GBCAs) was more likely than another type of GBCA (macrocyclic GBCAs) to result in retention of gadolinium in the body. First Amended Complaint ¶¶ 38-39 [#49] (“Complaint”). However, the manufacturers of Magnevist and other GBCAs did not share this information with consumers or physicians. Compl. ¶ 46. Based on evidence of an association between GBCAs and a type of kidney disease, the FDA released a warning regarding the release of gadolinium from linear GBCAs like Magnevist in 2007. Compl. ¶ 47. Defendants also revised the label for Magnevist at that time to include a contraindication for use in people with kidney disease and injury. Compl. ¶ 48.

         Around 2012 or 2013, researchers identified evidence that gadolinium retention was connected to illness in patients with normal kidney function. Compl. ¶¶ 52-57. In July 2015, the FDA released a public safety alert that it was investigating the risk of gadolinium retention from repeated use of GBCAs. Compl. ¶ 55. In September 2017, after the FDA voted to add concerns about gadolinium retention on warning labels, GBCA manufacturers, including Defendants, issued a new joint warning to patients with normal kidney function. Compl. ¶¶ 56-57. This warning communicated that gadolinium is retained for months to years, even in healthy patients, and that this retention was more pronounced with linear GBCAs. The warning also directed physicians to advise patients of these concerns. Compl. ¶ 57.

         Until recently, members of the medical community generally were not aware of any disease associated with gadolinium for patients with normal kidney function. Compl. ¶ 50.

         Plaintiff claims that Defendants failed to properly warn him of the risks posed by linear GBCAs such as Magnevist in 2010 and failed to communicate that there were safer alternatives available (macrocylic GBCAs). Compl. ¶ 27. As a result of being administered Magnevist, Plaintiff continues to have detectable levels of gadolinium in his body. Compl. ¶ 33. This retained gadolinium can result in fibrosis in organs, skin, and bones, retained gadolinium in the brain, and related injuries. Compl. ¶ 28. Plaintiff alleges that the retained gadolinium has in fact caused him “severe and permanent physical and emotional injuries, including, but not limited to, gadolinium retention in multiple organs . . . the resulting fibrosis in organs, bone, and skin, and its tendency to cross the blood-brain barrier and deposit in . . . the brain.” Compl. ¶ 88.

         II. Procedural Background

         Plaintiff filed his initial Complaint [#1] in the Northern District of California in October 2017. The parties agreed to transfer venue to the District of Massachusetts, the district in which Plaintiff stipulated that the Magnevist was allegedly administered. Parties’ Stipulation 4-5 [#24]. However, Defendants expressly reserved the right to challenge personal jurisdiction in this district. Id at 2. On April 6, 2018, the case was transferred to this district pursuant to 28 U.S.C. § 1406(a). Order [#25].

         Following transfer, Plaintiff filed an Amended Complaint [#49] and Defendants filed the pending Motion to Dismiss [#54], which Plaintiff has opposed. Pl.’s Opp’n [#61].

         III. Discussion

         A. Personal Jurisdiction

         Defendants assert first that the action must be dismissed for lack of personal jurisdiction. Two types of personal jurisdiction are recognized under the federal Constitution: “‘general’ (sometimes called ‘all-purpose’) jurisdiction and ‘specific’ (sometimes called ‘case-linked’) jurisdiction.” Bristol-Myers Squibb Co. v. Super. Ct. of Cal., 137 S.Ct. 1773, 1780 (2017). Plaintiff concedes that the court does not possess general jurisdiction over Bayer. Pl.’s Opp’n 4 [#61]. For specific jurisdiction, the court must consider: (1) whether the claims arise out of or are related to the defendant’s in-state activities (“relatedness”), (2) whether the defendant has purposefully availed itself of the laws of the forum state (“purposeful availment”), and (3) whether the exercise of jurisdiction is reasonable under the circumstances (“reasonableness”). Nowak v. Tak How Investments, Ltd., 94 F.3d 708, 712-713 (1st Cir. 1996).

         Plaintiff contends that an analysis of Massachusetts’ long-arm statute is unnecessary since the bounds of the long-arm statute are coterminous with the bounds of the federal Constitution for the purpose of assessing personal jurisdiction. Pl.’s Opp’n 4-5 [#61] (citing cases). “But in recent cases, [the First Circuit] ha[s] suggested that the Commonwealth's long-arm statute may impose limits on the exercise of personal jurisdiction more restrictive than those required by the Constitution.” A Corp. v. All Am. Plumbing, Inc., 812 F.3d 54, 59 (1st Cir. 2016) (reviewing cases) (internal citation omitted). Accordingly, in this diversity action, the court must also consider the forum’s long-arm statute. Sawtelle v. Farrell, 70 F.3d 1381, 1387 (1st Cir. 1995). In Massachusetts, that statute is Mass. Gen. Laws ch. 223A, § 3. Section 3(a), for example, provides jurisdiction over companies “transacting any business in this commonwealth.” Mass. Gen. Laws ch. 223 A, § 3(a). This section has been consistently interpreted to require that the transactions occurring in this ...

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